The agency announced Thursday that it had approved Daytrana for use by
children aged 6 to 12. The patch is manufactured by Noven Pharmaceuticals and
Shire Pharmaceuticals.

Daytrana contains the active ingredient methylphenidate, the same stimulant
drug used in popular oral medications such as Ritalin and Concerta.

Those drugs have recently been under scrutiny at the FDA. Two separate
advisory committees have recommended stronger warnings for ADHD drugs because of
reports suggesting that they may contribute to increased heart attack and stroke
risk in adults and a danger of psychiatric side effects, including suicidal
behaviors, in children.

Warnings of Side Effects

Daytrana's label contains warnings of possible psychiatric side effects and
alerts doctors not to prescribe it in children with structural heart
abnormalities. Those warnings are common to all methylphenidate drugs.

But the advisory committees have recommended new warnings to make it clearer
to doctors and patients that cardiovascular and psychiatric side effects can
occur.

The agency is "actively considering" those recommendations but has not yet
made a decision," Thomas Laughren, MD, head of FDA's division of psychiatric
products, told reporters.

"There's the standard language in labeling" for the patch, he said.

Shire spokesman Matthew Cabrey declined to disclose how many doctors are
expected to prescribe the drug.

An FDA advisory panel of outside experts unanimously recommended Daytrana for
approval in December. The panel also unanimously urged doctors to prescribe the
drug only for children who cannot or would not take pills.

The patch has been shown to reduce ADHD symptoms about as well as other oral
treatments. But the FDA rejected the patch in 2003 because concerns over
insomnia, tics, weight loss, and other side effects outweighed its benefits. New
data presented by Shire and Noven Pharmaceuticals helped sway experts late last
year.